Mesenteric Artery IschemiaBOWELNCT04686981
Endovascular thromBectomy of Acute Mesentery Vessels Occlusion Hybrid With Emergent Laparoscopic Surgery
An observational study of Mesenteric Artery Ischemia and Thromboembolism, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Acute mesenteric artery thromboembolism(AMT) is one of the important causes of acute abdomen and intestinal necrosis. If the intestinal blood supply is not restore in time, the prognosis of the disease is often poor and even endangers the life of the patient. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mesenteric Artery Ischemia, Thromboembolism
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Jul 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients suffering from superior mesenteric artery thromboembolism
Who may be able to join
- Patients with intestinal ischemia and acute abdomen pain caused by superior mesenteric artery thromboembolism
Who cannot join
- Those who have acute large-area myocardial infarction, large-area cerebral infarction, or have serious heart failure or sequelae of cerebral infarction within 1 month;
- Combined with portal hypertension, gastrointestinal hemorrhage, portal and mesenteric venous reflux obstruction diseases;
- Contrast agent allergy, severe renal insufficiency, and inability to perform intravascular surgery;
- Past medical history contains superior mesenteric artery thromboembolism.
- Patients diagnosed with intestinal necrosis and peritonitis before surgery based on physical signs and imaging studies who directly undergo laparotomy and incision for thrombectomy.
- Patients without intestinal necrosis or peritonitis based on physical signs and imaging studies, who are treated by endovascular intervention therapy directly.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, 102218
About this study
Official title: Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
Acute mesenteric artery thromboembolism(AMT) is one of the important causes of acute abdomen and intestinal necrosis. If the intestinal blood supply is not restore in time, the prognosis of the disease is often poor and even endangers the life of the patient. Through laparoscopic surgery combined with modern minimally invasive endovascular technology, the blood supply of patients' intestine is restored. Observe the perioperative vascular patency rate, all-cause mortality, and the probability of short bowel syndrome. Through the hybrid operating room, we want to seek a multidisciplinary collaborative treatment mode to improve the long-term survival rate of such patients with enough intestines and completely free from TPN, and improve the prognosis of these patients.
Read the detailed description
This study is a clinical cohort study; consecutively registered 30 patients with acute intestinal ischemia caused by superior mesenteric artery thromboembolism.
If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy.
The main endpoints are the survival rate of bowel function preserved at 30 days, and the secondary endpoints are 30-day mortality, in-hospital mortality, symptoms-free survival rate, and rate of transition to laparotomy.
- Conditions
- Mesenteric Artery Ischemia, Thromboembolism
- Keywords
- Acute mesenteric artery thrombosis, Hybrid operation, Mechanical thrombectomy
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mesenteric artery thromboembolism patients | If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate with preserved bowel function
Counting data
Measured: within 30 days after operations
Secondary outcomes (2)
the incidence of all-cause mortality
Counting data
Measured: within 30 days after operations
vascular patency rate
Counting data
Measured: 180 days after operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mesenteric Artery IschemiaStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiwei Wu, Beijing Tsinghua Chang Gung Hospital
- Investigators
- sifan yang, Study director, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686981
- Sponsor's protocol ID
- 20283-0-01
- Acronym
- BOWEL
- Status last verified
- Mar 2024
- First submitted
- 16 Dec 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo S, Zhao K, Zhu R, Cao Z, Zhang P, Li Y, Wu W. Selective minimally invasive strategy for acute superior mesenteric artery obstruction. J Vasc Surg. 2025 May;81(5):1083-1091.e1. doi: 10.1016/j.jvs.2025.01.033. Epub 2025 Jan 21.
PubMed 39848506
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
- ClinicalTrials.gov ID
- NCT04686981
- Acronym / sponsor ID
- BOWEL / 20283-0-01
- Conditions
- Mesenteric Artery Ischemia, Thromboembolism
- Keywords
- Acute mesenteric artery thrombosis, Hybrid operation, Mechanical thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute mesenteric artery thromboembolism(AMT) is one of the important causes of acute abdomen and intestinal necrosis. If the intestinal blood supply is not restore in time, the prognosis of the disease is often poor and even endangers the life of the patient. Through laparoscopic surgery combined with modern minimally invasive endovascular technology, the blood supply of patients' intestine is restored. Observe the perioperative vascular patency rate, all-cause mortality, and the probability of short bowel syndrome. Through the hybrid operating room, we want to seek a multidisciplinary collaborative treatment mode to improve the long-term survival rate of such patients with enough intestines and completely free from TPN, and improve the prognosis of these patients.
Detailed description
This study is a clinical cohort study; consecutively registered 30 patients with acute intestinal ischemia caused by superior mesenteric artery thromboembolism.
If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy.
The main endpoints are the survival rate of bowel function preserved at 30 days, and the secondary endpoints are 30-day mortality, in-hospital mortality, symptoms-free survival rate, and rate of transition to laparotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenteric artery thromboembolism patients | – | –If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients suffering from superior mesenteric artery thromboembolism
Key inclusion criteria (1 listed)
- Patients with intestinal ischemia and acute abdomen pain caused by superior mesenteric artery thromboembolism
Key exclusion criteria (6 listed)
- Those who have acute large-area myocardial infarction, large-area cerebral infarction, or have serious heart failure or sequelae of cerebral infarction within 1 month;
- Combined with portal hypertension, gastrointestinal hemorrhage, portal and mesenteric venous reflux obstruction diseases;
- Contrast agent allergy, severe renal insufficiency, and inability to perform intravascular surgery;
- Past medical history contains superior mesenteric artery thromboembolism.
- Patients diagnosed with intestinal necrosis and peritonitis before surgery based on physical signs and imaging studies who directly undergo laparotomy and incision for thrombectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival rate with preserved bowel function
Time frame: within 30 days after operations
Counting data
2 secondary outcomes
the incidence of all-cause mortality
Time frame: within 30 days after operations
vascular patency rate
Time frame: 180 days after operations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 39848506Guo S, Zhao K, Zhu R, Cao Z, Zhang P, Li Y, Wu W. Selective minimally invasive strategy for acute superior mesenteric artery obstruction. J Vasc Surg. 2025 May;81(5):1083-1091.e1. doi: 10.1016/j.jvs.2025.01.033. Epub 2025 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sifan yang study director
Beijing Tsinghua Chang Gung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesenteric Artery Ischemia and Thromboembolism, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate with preserved bowel function (time frame: within 30 days after operations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.